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Elite 900-1228-315-3

by Ortho Organizers, Inc.

Elite 900-1228-315-3 is a Class I device made by Ortho Organizers, Inc., listed in FDA GUDID since 8 Sep 2017 (UDI-DI 00190707026790), registry data as of 23 Oct 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00190707026790 UDI-DI Date8 Sep 2017ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade name
Elite
Generic name
Orthodontic metal band
Model / reference
900-1228-315-3
Primary DI / UDI-DI
00190707026790
FDA product code
ECM
GMDN term
Orthodontic metal band
Device class
Class I
Regulation number
872.5410
GUDID distribution status
In Commercial Distribution

Related devices

Category: Orthodontic metal band

Other devices from Ortho Organizers, Inc.

See all devices from Ortho Organizers, Inc. →

Properties

  • Single use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
Other properties (11, all answered No)